Other: Cyclobenzaprine (Flexeril®) 5 mg: Symptom response and concomitant analgesic use in patients with acute painful muscle spasm

Abstract

The aim was to describe symptom response and concomitant analgesic use in patients treated with cyclobenzaprine (Flexeril®) 5 mg for acute painful muscle spasm. Prospective, open-label, multi-center, 7-day study of cyclobenzaprine 5 mg tid (CYC5) in patients with acute painful muscle spasm of the back or neck (N=468). Median duration of pain prior to entering the study was 7 days. Patient-rated clinical global impression of change (PCGI) was assessed after 7 days of CYC5 therapy using a 5-point scale from 0-4, with 0=worse and 4=marked improvement. Symptom response was defined as the percentage of patients reporting mild, moderate, or marked improvement on the PCGI. Patients used diary cards to record their concomitant therapies. Mean age of patients was 40 years and 54% were female. Symptom response with CYC5 was 90% among patients who completed a 7 day course of therapy (n=410). Sixty-three percent of patients (n=449) took concomitant therapies. Among these patients, 158 (35%) took analgesics for ≥1 day(s). Most common concomitant analgesics were ibuprofen and acetaminophen. In this prospective study, CYC5 was associated with a high response rate in patients with acute painful muscle spasm. Ibuprofen and acetaminophen were the most common concomitant analgesics.